Integrated Biologics

The right biologics CDMO brings a combination of scientific expertise, GMP manufacturing capabilities, established technology platforms, and the ability to support your program across the full CMC pathway from early development to commercial supply. Strong partners bring proven experience in biologics drug development, integrated drug substance and drug product capabilities, tech transfer expertise, and regulatory support across IND and commercial milestones. Lonza provides integrated, end-to-end contract development and manufacturing services for biologics to help you simplify your supply chain and mitigate CMC risk as programs scale. This is particularly important for more complex biologics like bispecifics and ADCs, where integrated CMC expertise and a proven commercialization track record are critical.

Good to know: Many programs start with a focused scope and expand as the project progresses.

Reducing CMC risk and accelerating timelines requires early focus on manufacturability, robust analytics, and phase-appropriate development strategies aligned to regulatory requirements. Lonza’s early development services, rapid tox and DNA-to-IND programs combine platform expression, formulation, and phase appropriate analytics to shorten development cycles and improve manufacturability.

These programs provide an IND enabling CMC package aligned around your milestones and supported with clear documentation. This includes coordinated support for formulation development, clinical trial supply, and drug product manufacturing alongside drug substance development.

Flexible engagement models allow you to match scope and pace to your funding and strategy.

Good to know:

An integrated biologics CDMO provides end-to-end support across development and manufacturing, including cell line, process and analytical development, GMP clinical supply, tech transfer, and commercial manufacturing. By aligning drug substance and drug product activities within one partner, this model improves data continuity, reduces delays during scale-up and site transfers, and enables more predictable timelines across the full lifecycle—an important advantage for complex biologics in an increasingly constrained and regulated environment.

Integrated networks further help mitigate supply and timeline risks by combining global manufacturing capacity, proactive capacity planning, and coordinated governance, ensuring consistent execution from early development through commercial supply.

Good to know: Integrated approaches reduce fragmentation, strengthen supply continuity, and support smoother progression to commercial manufacturing.

An integrated CDMO should provide integrated digital and data capabilities that enable real-time visibility, informed decision-making, and consistent control across drug substance and drug product programs. This includes continuous data streams supported by process analytical technologies (PAT), integrated data platforms, and advanced analytics to improve process understanding and scalability.

At Lonza, these capabilities are embedded within a structured operating model that combines digital tools with clear governance, defined escalation pathways, and dedicated cross-functional teams. This allows for data to be actionable—supported by milestone reviews and direct access to experts across process development, quality, and manufacturing. Standardized communication and digital collaboration tools further enable alignment across global sites and support consistent execution from early development through commercial supply.

Good to know:

A smooth tech transfer requires strong planning, cross‑functional collaboration, and deep GMP experience. Our teams bring decades of GMP biologics manufacturing experience and a proven track record of quality and compliance across more than 300 successful tech transfers. Through facility-fit assessments, gap analyses, dedicated project and account management and integrated DS/DP capabilities with full in-house analytics/QC, and real time reporting, we help ensure rapid resupply and efficient progression to PPQ and commercial manufacturing across our global GMP network.

Good to know: Gap analyses mitigate risks while governance checkpoints keep decisions fast and transparent.